(provided by the applicant): This is an application to renew a clinical trials unit (CTU) in Botswana, which has the second-highest prevalence of HIV in the world but also a sympathetic and interested government. This program will engage in research related to adult HIV therapeutic strategies (including antiretroviral treatment strategies, the diagnosis/management of noninfectious co-morbidities, and the infectious co-morbidities of hepatitis and tuberculosis);strategies to address HIV and HIV-associated infections/conditions in piediatric and maternal populations;integrated HIV prevention strategies in pediatric and adult populations;and vaccines to prevent HIV infection. These activities will occur through participation in four networks: ACTG, IMPAACT, HPTN, and HVTN. The objectives are to help develop and facilitate strategies for prevention and treatment of HIV infection and HIV-related illnesses (and for HIV vaccines) that are relevant for alleviating the epidemic in sub-Saharan Africa and elsewhere. Investigators and other key personnel from the Botswana CTU will participate in and contribute to network scientific and leadership activities in all areas, including joining and potentially leading protocol teams and scientific / resource committees ofthe networks with which this CTU will be affiliated. The Botswana CTU will conduct an integrated program for clinical research that includes clinical and laboratory activities. Two established clinical research sites (in Gaborone and Molepolole) will be affiliated with this CTU, and will allow efficient enrollment of participants in both urban and village populations into trials in Botswana. The investigators and staff are highly experienced in AIDS research, including trials in all proposed research areas, and have a strong record of collaboration with national and international agencies and networks, and a substantial record of having completed trials with very high standards. The combined resources of the Botswana CTU are substantial for both facilities and personnel.

Public Health Relevance

The Botswana CTU will develop and study strategies for preventing and treating HIV infection and HIV-related illnesses that are relevant to the severe HIV epidemic in sub-Saharan Africa and elsewhere. This will include studies related to treating HIV in HIV-infected adults and children;preventing sexual and perinatal transmission of HIV;improving the health of HIV-infected mothers and their children;and studying vaccines designed to prevent the transmission of HIV.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-VV-A (S1))
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Tauscher, Gail H
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Harvard University
Schools of Public Health
United States
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Naranbhai, Vivek; Kim, Soyeon; Fletcher, Helen et al. (2014) The association between the ratio of monocytes:lymphocytes at age 3 months and risk of tuberculosis (TB) in the first two years of life. BMC Med 12:120
Shaffer, Douglas; Hughes, Michael D; Sawe, Fredrick et al. (2014) Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE). J Acquir Immune Defic Syndr 66:155-63
Nachman, Sharon; Zheng, Nan; Acosta, Edward P et al. (2014) Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years. Clin Infect Dis 58:413-22
Grinsztejn, Beatriz; Hosseinipour, Mina C; Ribaudo, Heather J et al. (2014) Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis 14:281-90
Asmelash, Aida; Zheng, Yu; Kaloustian, Kara Wools et al. (2014) Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa. BMC Infect Dis 14:331
Zheng, Yu; Hughes, Michael D; Lockman, Shahin et al. (2014) Antiretroviral therapy and efficacy after virologic failure on first-line boosted protease inhibitor regimens. Clin Infect Dis 59:888-96
Shiboski, C H; Chen, H; Ghannoum, M A et al. (2014) Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253. Int J Tuberc Lung Dis 18:682-8
Paredes, Roger; Marconi, Vincent C; Lockman, Shahin et al. (2013) Impact of antiretroviral drugs in pregnant women and their children in Africa: HIV resistance and treatment outcomes. J Infect Dis 207 Suppl 2:S93-100